Simplifying an FDA regulated process that protects people during clinical trials

After envisioning the future of IRB submission, our team moved on to design and develop a new IRB (Institutional Review Board) submission platform for WCG. This platform is used by clinical trial associates who are responsible for IRB submission, an FDA regulated process that protects human research subjects.

The original submission process was confusing and lead to mistakes. Users needed an experience that was easy to use and supported them in completing their work quickly and accurately.

Research informed design

The client asked design to lead in shaping requirements. We needed to drive our design decisions with insights from the initial research phase and continue validating our work through usability testing.

We worked with the client identify the core features that would make up the MVP, balancing user needs and business priorities.

We were tasked to design, implement, and launch the first release in only 6 months.

Establishing a framework

A core part of our design effort was taking a set of disjointed, unwieldy PDF smart forms and bring them together into one unified experience. The client required forms to be built with form.io, a drag and drop form builder. Since this meant we would have limited control over form element functionality and styling, we focused on establishing the UX framework.

A Simple Set Up

We found that users carried the burden of figuring out which sections are required for submission, depending on the individual submission.

• A brief set up flow asks the important questions up front

• A flexible navigation allows users to jump around the workflow

• Simple visual statuses to indicate progress

A component-based approach

To streamline hand-off between design and front-end implementation, we began design by creating a foundational UI Kit of components and we evolved the kit as requirements developed.

We extended an existing digital marketing brand to develop a set of components that would support an authenticated task-based experience. 

This UI Kit was translated to a component library, now implemented across the clients’ suite of digital products.